Medical Device Consulting Services for South Korea

Through our colleagues in Seoul, South Korea, we can fully assist you with all aspects of compliance with Korea Food and Drug Administration (KFDA) medical device regulations, including registration, quality system compliance and distributor evaluation. Our services for medical device companies entering the Korean market are shown below.

Korean KFDA Medical Device Registration

Our colleagues in Seoul understand the nuances of the Korean medical device registration process and maintain an excellent relationship with officials from the KFDA.

General and SER Technical File Compilation for the Korean KFDA

Our consulting team is experienced with a wide array of medical devices, from low risk Class I products to high risk Class IV devices.

Korea KGMP Quality System Compliance

Let us help ensure that you are in full compliance with Korean KGMP requirements and prepared for a KFDA audit of your Registration Holder.

Third Party License Holder Representation in South Korea

We can help you with independent regulatory representation in South Korea as a way to help you maintain more control over your medical device registration.

Click on the image to download this PDF of the medical device approval process in Korea